Crimping tool for prosthetic heart valve

Abstract

The invention provides a crimping apparatus and method for securing a prosthetic valve onto a delivery system. The apparatus includes a set of graspers configured to grasp the distal end of the prosthetic valve, a hollow crimping shaft that collapses the graspers from an open to a closed position as they slide into the shaft, thereby crimping the distal end from its maximum uncrimped diameter to a fully crimped diameter, and a funnel coupled to the proximal end of the shaft. The hollow crimping shaft slides proximally relative to the graspers, causing the funnel to slide over the prosthetic valve from the crimped distal end. As the funnel slides, its inner wall crimps the remainder of the valve to the fully crimped diameter, and the shaft continues to slide until the fully crimped valve is entirely within the shaft.

Description

[0001] CRIMPING TOOL FOR PROSTHETIC HEART VALVE

[0002] FIELD OF THE INVENTION

[0003] Some applications of the present invention relate in general to valve replacement . More specifically, some applications of the present invention relate to delivery tools for prosthetic valves for replacement of a cardiac valve .

[0004] BACKGROUND

[0005] Transcatheter replacement of a heart valve is a treatment for various cardiac diseases . Loading a prosthetic heart valve onto a transcatheter delivery system often requires the prosthetic heart valve to be crimped so as to reduce the diameter of the prosthetic heart valve for transcatheter delivery .

[0006] US 8 , 468 , 667 to Straubinger et al . describes a device for compress ing a stent or a stent with a prosthetic heart valve affixed thereto, as well as a method for loading a stent into a medical delivery system. The device may comprise a compress ing mechanism des igned so as to exert a compress ive force in radial direction on at least parts of a stent accommodated within the compress ing mechanism such that the cross -section of the stent is reduced to a prede finable value at least at certain areas . The device may further comprise a manipulating mechanism moveable relative to the compres sing mechanism for moving at least one clamping means in the radial direction in order to adj ust the internal cross -sectional diameter of the compres sing mechanism . Other applications are also described .

[0007] US 2021 / 0196460 to Achiluz zi et al . describes a loading system for implantable prostheses , speci fically heart valve prostheses . The loading system may be pre-mounted in a storage container filled with a preservation solution with the prosthesis attached thereto, and may provide one or more deployment elements of a delivery instrument as receivers for the loading of the prosthes is . Other applications are also described . SUMMARY OF THE INVENTION

[0008] For some applications , a method and apparatus for crimping a prosthetic valve onto a delivery system are provided . For some applications , the crimping of the prosthetic heart valve has two phases : a first phase in which a distal end of the prosthetic heart valve is crimped from a maximum diameter of the prosthetic valve to a fully crimped diameter of the prosthetic valve , and a second phase in which the remainder of the prosthetic heart valve is crimped to the fully crimped diameter . At the end of the crimping proces s , the crimped prosthetic valve is disposed entirely ins ide a hollow crimping shaft and is ready to be trans ferred to a delivery capsule of a transcatheter delivery system . The prosthetic valve remains crimped along the entire length of the prosthetic valve ( i . e . , from the distal end of the prosthetic valve to a proximal end of the prosthetic valve ) during the trans fer to the delivery capsule and subsequently while disposed within the delivery capsule .

[0009] For some applications , in the first phase of the crimping a set of graspers is used to grasp the distal end of the prosthetic valve . The graspers collapse from an open pos ition to a closed pos ition as the graspers slide at least partially into the hollow crimping shaft . As the graspers holding the distal end of the prosthetic valve collapse to the closed pos ition, the distal end of the prosthetic valve is thereby crimped . For some applications , the crimping shaft has a funnel coupled to a proximal end of the hollow crimping shaft and the crimping of the remainder of the prosthetic valve in the second phase of the crimping is achieved by s liding the hollow crimping shaft and the funnel in a proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve . As the funnel and the crimping shaft slide over the prosthetic valve , the gradually decreasing diameter of the inner wall of the funnel crimps the remainder of the prosthetic valve to the fully crimped diameter thus enabling the hollow crimping shaft to slide over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely ins ide the hollow crimping shaft .

[0010] It is noted that, for some applications , although both phases of the crimping involve a relative linear motion between the hollow crimping shaft and the prosthetic valve , the actuation of the two phases may be by di fferent mechanisms . For example , for some applications , the first phase of the crimping is actuated by linearly pulling the set of graspers at least partially into the hollow crimping shaft , whereas the second phase of the crimping is actuated by rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the set of closed graspers , thereby causing the funnel to s lide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .

[0011] There is therefore provided, in accordance with some applications of the present invention, a method for crimping a prosthetic valve onto a delivery system, the method including : crimping a distal end of the prosthetic valve from a maximum diameter of the prosthetic valve to a fully crimped diameter of the prosthetic valve ; and sliding a hollow crimping shaft that has a funnel coupled to a proximal end of the hollow crimping shaft in a proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve , such that ( a ) the inner wall of the funnel crimps the remainder of the prosthetic valve to the fully crimped diameter as the funnel slides over the prosthetic valve , and (b ) the hollow crimping shaft slides over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely ins ide the hollow crimping shaft .

[0012] For some applications , crimping the distal end of the prosthetic valve from the maximum diameter of the prosthetic valve to the fully crimped diameter of the prosthetic valve includes : grasping a distal end of the prosthetic valve with a set of graspers and collaps ing the graspers from an open pos ition to a closed pos ition by s liding the set of graspers at least partially into the hollow crimping shaft .

[0013] For some applications , grasping the distal end of the prosthetic valve includes grasping with the set of graspers a fabric portion of the prosthetic valve at the distal end of the prosthetic valve .

[0014] For some applications , grasping the distal end of the prosthetic valve includes grasping with the set of graspers a wire frame of the prosthetic valve at the distal end of the prosthetic valve . For some applications , sliding the hollow crimping shaft that has the funnel coupled to the proximal end of the hollow crimping shaft in the proximal direction includes rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the set of closed graspers , thereby causing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .

[0015] For some applications , grasping the distal end of the prosthetic valve with the set of graspers comprises grasping the distal end of the prosthetic valve with a set of 3 -9 graspers .

[0016] For some applications , sliding the set of graspers at least partially into the hollow crimping shaft includes linearly pulling on a graspers ' shaft in a distal direction with respect to a housing until the graspers ' shaft engages with a lock such that further linear motion of the graspers ' shaft with respect to the hous ing is inhibited, wherein :

[0017] (a ) the graspers ' shaft is coaxial with the hollow crimping shaft , at least a portion of the graspers ' shaft is disposed within the hollow crimping shaft , and at least a portion of the hollow crimping shaft is disposed within the hous ing,

[0018] (b ) linearly pulling on the graspers ' shaft in the distal direction includes linearly pulling on the graspers ' shaft in the distal direction while the hollow crimping shaft remains stationary with respect to the housing, and

[0019] (c ) the graspers ' shaft is rigidly coupled to a first end of each grasper of the set of graspers , wherein a second end of each grasper , oppos ite the first end, grasps the distal end of the prosthetic valve such that as the graspers ' shaft is linearly pulled in the distal direction the set of graspers slides at least partially into the hollow crimping shaft, the hollow crimping shaft causing the set of graspers to move from the open pos ition to the closed position as the set of graspers s lide at least partially into the hollow crimping shaft .

[0020] For some applications , linearly pulling on the graspers ' shaft in the distal direction with respect to the hous ing until the graspers ' shaft engages with the lock includes linearly pulling on the graspers ' shaft a distance of 20-100 mm. For some applications , sliding the hollow crimping shaft that has the funnel coupled to the proximal end of the hollow crimping shaft in the proximal direction includes rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the housing, the graspers ' shaft being in a state in which the graspers ' shaft is engaged with the lock, thereby caus ing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .

[0021] For some applications , rotating the crimping knob includes caus ing the hollow crimping shaft to s lide linearly 50-80 mm in the proximal direction with respect to the hous ing .

[0022] There is further provided, in accordance with some applications of the present invention, crimping apparatus for crimping a prosthetic valve onto a delivery system, the apparatus including : a set of graspers configured to grasp a distal end of the prosthetic valve ; a hollow crimping shaft arranged with respect to the graspers such that the graspers (a ) collapse from an open pos ition to a closed position as the graspers s lide at least partially into the hollow crimping shaft, thereby (b ) crimping the distal end of the prosthetic valve from a maximum uncrimped diameter of the distal end of the prosthetic valve to a fully crimped diameter of the prosthetic valve ; and a funnel coupled to a proximal end of the hollow crimping shaft , the hollow crimping shaft arranged to s lide in a proximal direction with respect to the set of graspers such that ( a) the funnel s lides in a proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve , whereby the inner wall of the funnel crimps the remainder of the prosthetic valve to the fully crimped diameter , and (b) the hollow crimping shaft s lides over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely ins ide the hollow crimping shaft .

[0023] For some applications : the funnel has a longitudinal axis , at any point x along the longitudinal axis the inner wall of the funnel has a radius r, and the second derivative d2 r / dx2 of the radius with respect to position x along the longitudinal axis is positive in a distal portion of the funnel and negative in a proximal portion of the funnel .

[0024] For some applications , the set of graspers includes 3-9 graspers .

[0025] For some applications , a height of the funnel from a proximal end of the funnel to a distal end of the funnel is 40-60 mm .

[0026] For some applications , the fully crimped diameter of the prosthetic valve is 4-11 mm.

[0027] For some applications , a maximum uncrimped diameter of a proximal end of the prosthetic valve is 16-32 mm .

[0028] For some applications , a maximum uncrimped diameter of the distal end of the prosthetic valve is 22 -44 mm .

[0029] For some applications , a ratio of ( i ) a maximum uncrimped diameter of the distal end of the prosthetic valve to ( ii ) a maximum uncrimped diameter of a proximal end of the prosthetic valve is 1 -2 .

[0030] For some applications , a ratio of ( i ) a maximum uncrimped diameter of the distal end of the prosthetic valve to ( ii ) a fully crimped diameter of the prosthetic valve is 2 -11 .

[0031] For some applications , an uncrimped length of the prosthetic valve from the distal end of the prosthetic valve to a proximal end of the prosthetic valve is 10-40 mm.

[0032] For some applications , upon the remainder of the prosthetic valve being crimped, a fully crimped length of the prosthetic valve from the distal end of the prosthetic valve to a proximal end of the prosthetic valve is 15-50 mm .

[0033] For some applications , an uncrimped length of the prosthetic valve from the distal end of the prosthetic valve to a proximal end of the prosthetic valve is 10-40 mm.

[0034] For some applications , a ratio of ( i ) a fully crimped length of the prosthetic valve to ( ii ) an uncrimped length of the prosthetic valve is 1 - For some applications , the set of graspers is configured to grasp the distal end of the prosthetic valve by grasping a fabric portion of the prosthetic valve at the distal end of the prosthetic valve .

[0035] For some applications , the set of graspers is configured to grasp the distal end of the prosthetic valve by grasping a wire frame of the prosthetic valve at the distal end of the prosthetic valve .

[0036] For some applications , the apparatus further includes a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the set of closed graspers , thereby caus ing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .

[0037] For some applications , the crimping knob and the hollow crimping shaft are arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly 50-80 mm in the proximal direction with respect to the set of closed graspers .

[0038] For some applications , the apparatus further includes :

[0039] (A) a hous ing, at least a portion of the hollow crimping shaft disposed within the hous ing;

[0040] (B) a graspers ' shaft :

[0041] ( i ) disposed coaxially with the hollow crimping shaft, at least a portion of the graspers ' shaft disposed within the hollow crimping shaft,

[0042] ( ii ) rigidly coupled to a first end of each grasper of the set of graspers , wherein a second end of each grasper, oppos ite the first end, grasps the distal end of the prosthetic valve , and

[0043] ( iii ) configured to be linearly pulled in a distal direction with respect to the hous ing while the hollow crimping shaft remains stationary with respect to the hous ing, thereby caus ing the set of graspers to slide at least partially into the hollow crimping shaft , the hollow crimping shaft caus ing the set of graspers to move from the open position to the closed position as the set of graspers s lide at least partially into the hollow crimping shaft, and

[0044] (C) a lock arranged such that the graspers ' shaft engages with the lock once the set of graspers has moved to the closed position, the lock configured to inhibit further linear motion of the graspers ' shaft with respect to the hous ing .

[0045] For some applications , the lock and the graspers ' shaft are arranged such that the graspers ' shaft engages with the lock upon the graspers ' shaft being linearly pulled a distance of 20-100 mm in the distal direction with respect to the hous ing .

[0046] For some applications , the apparatus further includes a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the housing, the graspers ' shaft being in a state in which the graspers ' shaft is engaged with the lock, thereby causing the funnel to s lide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .

[0047] For some applications , the crimping knob and the hollow crimping shaft are arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly 50-80 mm in the proximal direction with respect to the hous ing .

[0048] There is further provided, in accordance with some applications of the present invention, a method for crimping a prosthetic valve onto a delivery system, the method including : crimping a distal end of the prosthetic valve by grasping the distal end of the prosthetic valve with a set of graspers and collapsing the graspers from an open pos ition to a closed position by linearly pulling the set of graspers at least partially into a hollow crimping shaft that has a funnel coupled to a proximal end of the hollow crimping shaft ; and crimping the remainder of the prosthetic valve by rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the set of closed graspers , thereby causing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve , such that the inner wall of the funnel crimps the remainder of the prosthetic valve as the funnel slides over the prosthetic valve . For some applications , as the inner wall of the funnel crimps the remainder of the prosthetic valve the hollow crimping shaft slides over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely inside the hollow crimping shaft .

[0049] The present invention will be more fully understood from the following detailed description of applications thereof , taken together with the drawings , in which :

[0050] BRIEF DESCRIPTION OF THE DRAWINGS

[0051] Fig . 1A shows a perspective view of a crimping apparatus for crimping a prosthetic valve , in accordance with some applications of the present invention ;

[0052] Fig . IB shows an exploded view of the crimping apparatus of Fig . 1A, in accordance with some applications of the present invention;

[0053] Fig . 2 shows a cross -sectional view of the crimping apparatus of Fig . 1A, in accordance with some applications of the present invention;

[0054] Fig . 3 shows a perspective view of the crimping apparatus of Fig . 1A with a cross -sectional cut out, in accordance with some applications of the present invention ;

[0055] Figs . 4A-B show a cross -sectional view of the crimping apparatus of Fig . 1A grasping a distal end of a prosthetic valve , in accordance with some applications of the present invention;

[0056] Figs . 5A-B show a perspective view and corresponding cross -sectional view of the crimping apparatus of Fig . 1A after completion of a first phase of crimping a prosthetic valve , in accordance with some applications of the present invention ;

[0057] Fig . 6 shows the introduction of a transcatheter delivery system to the crimping apparatus of Fig . 1A, in accordance with some applications of the present invention ;

[0058] Figs . 7A-B show a perspective view and corresponding cross -sectional view of the crimping apparatus of Fig . 1A, depicting a second phase of crimping the prosthetic valve , in accordance with some applications of the present invention ; and Figs. 8-10 shows respective perspective views of the crimping apparatus of Fig. 1A depicting a process of loading the crimped prosthetic valve onto the transcatheter delivery system, in accordance with some applications of the present invention.

[0059] DETAILED DESCRIPTION

[0060] Reference is now made to Figs. 1A-B, 2, and 3, which are schematic illustrations of a crimping apparatus 20 for crimping a prosthetic valve 22 (shown for example in Figs. 4A-B) , in accordance with some applications of the present invention. For some applications, crimping apparatus 20 includes an outer grip 24 which surrounds a housing 26. A hollow crimping shaft 28 is seated within a channel 30 of housing 26 such that at least a portion of hollow crimping shaft 28 is disposed within housing 26. Hollow crimping shaft 28 can slide linearly with respect to housing 26 along channel 30. Crimping shaft 28 includes at least one threaded protrusion 32 which protrudes laterally from within channel 30, e.g. , two threaded protrusions 32 as shown in Fig. IB. A hollow crimping knob 34 surrounds housing 26 and has interior threading that engages with threaded protrusions 32 such that rotation of crimping knob 34 causes hollow crimping shaft 28 to slide linearly with respect to housing 26. Hollow crimping shaft 28 further has a threaded portion 36 at a proximal end 38 of hollow crimping shaft 28. A funnel 40 is coupled to proximal end 38 of hollow crimping shaft 28 in a threaded manner via threaded portion 36.

[0061] As illustrated by the exploded view in Fig. IB, outer grip 24, housing 26, hollow crimping shaft 28, and crimping knob 34 are all disposed coaxially with each other around a common central longitudinal axis 42. Crimping apparatus 20 further includes a set of graspers 44, e.g. , a set of 3-9 graspers 44, seated initially in an open position at least partially within funnel 40. A graspers' shaft 46 is (a) rigidly coupled to a first end 48 of each grasper 44, and (b) coaxial with hollow crimping shaft 28. A second end 49 of each grasper, opposite the first end, grasps a distal end of prosthetic valve 22 (further described hereinbelow with respect to Figs. 4A-B) . A pulling actuator 50 is disposed at a distal end 52 of graspers' shaft 46 and is used to linearly pull graspers' shaft 46 in a distal direction, thereby pulling on graspers 44 in the distal direction. As described further hereinbelow, when graspers' shaft 46 is pulled in the distal direction, the set of graspers 44 is pulled in the distal direction causing graspers 44 to slide at least partially into hollow crimping shaft 28. It is noted that in Fig. 1A graspers 44 are shown seated entirely within funnel 40. This is for illustrative purposes and is not limiting. For example, as shown in Fig. 3 (also for illustrative purposes) graspers 44 can have an initial position that is partially protruding from funnel 40.

[0062] Fig. IB shows an exploded view of the various components of crimping apparatus 20 illustrating how they are all disposed coaxially with each other and fit together to form the crimping apparatus 20 as shown in Fig. 1A. Figs. 2-3 show different respective views of crimping apparatus 20, further illustrating how the components of crimping apparatus 20 are disposed with respect to each other. Fig. 2 shows a 2D cross-sectional view of crimping apparatus 20 and Fig. 3 shows a perspective view of crimping apparatus 20 with a 3D cut out showing two cross-section planes of crimping apparatus 20. It is also noted that crimping apparatus 20 includes a lock 54 that automatically engages with graspers' shaft 46 in order to lock graspers' shaft 46 in place with respect to housing 26 after graspers' shaft 46 is pulled a predetermined distance in the distal direction. Lock 54 is accessible from the outside of outer grip 24 so that a user may manually release lock 54 from engagement with graspers' shaft 46. Lock 54 is further described hereinbelow with reference to Figs. 5A-B

[0063] Throughout this application, including the specification and the claims, unless stated otherwise, "proximal" and "distal, " are defined with respect to direction of delivery of the implant into the patient. Proximal means closer to the point of access into the patient, and distal means further from the point of access into the patient, i.e. , prosthetic valve 22 enters the patient's body with its distal end first.

[0064] Reference is now made to Figs. 4A-B, which are schematic illustrations showing a cross-sectional view of crimping apparatus 20 and prosthetic valve 22 in an initial position before crimping has begun, in accordance with some applications of the present invention. Set of graspers 44 is shown grasping a distal end 56 of prosthetic valve 22. It is noted that graspers 44 may grasp prosthetic valve 22 either by (i) grasping a wire frame 58 of prosthetic valve 22 at distal end 56 of prosthetic valve 22 , or ( ii ) grasping a fabric portion 60 of prosthetic valve 22 at distal end 56 of prosthetic valve 22 , e . g . , a fabric portion in between struts of wire frame 58 of prosthetic valve . Fig . 4A shows an enlarged view of prosthetic valve 22 with graspers 44 grasping onto the fabric in between the struts of wire frame 58 . Fig . 4B shows an enlarged view of prosthetic valve 22 with graspers 44 grasping the struts of wire frame 58 . Fig . 4B further shows graspers 44 grasping the struts of wire frame 58 in two different orientations of prosthetic valve 22 with respect to graspers 44 , illustrated by enlarged views 59 and 61 . This is to illustrate that graspers 44 do not need to be lined up with speci fic struts of wire frame 58 but rather graspers 44 can grasp any of the struts of wire frame 58 regardles s of the rotational orientation of prosthetic valve 22 . For illustrative clarity, Fig . 4B shows prosthetic valve 22 without the fabric portion attached to the prosthetic valve . For some applications , set of graspers 44 includes 3 -9 graspers pos itioned such that they grasp prosthetic valve in an evenly-distributed manner around a perimeter of distal end 56 of prosthetic valve 22 .

[0065] For some applications , funnel 40 has a longitudinal axis 111 . At any point x along longitudinal axis 111 the inner wall 41 of funnel 40 has a radius r . Inner wall 41 is shaped such that the second derivative d2 r / dx2 of the radius r with respect to position x along longitudinal axis 111 is pos itive in a distal portion 113 of funnel 40 and negative in a proximal portion 115 of funnel 40 . Shaping inner wall 41 in this way helps inner wall 41 of funnel 40 crimp the remainder of prosthetic valve 22 as the diameter of funnel 40 gradually decreases , as described hereinbelow with respect to Figs . 7A-B .

[0066] Re ference is now made to Figs . 5A-B, which are schematic illustrations showing, respectively, a perspective view and corresponding cros s -sectional view of crimping apparatus 20 after completion of a first phase of crimping prosthetic valve 22 . For some applications , in a first phase of the crimping, distal end 56 of prosthetic valve 22 is crimped from a maximum diameter Dla of distal end 56 of prosthetic valve 22 ( shown in Fig . 4B) of prosthetic valve 22 to a fully crimped diameter D2 of prosthetic valve 22 . As described hereinabove , graspers 44 grasp distal end 56 of prosthetic valve , and hollow crimping shaft 28 is arranged with respect to graspers 44 such that graspers 44 (a) collapse from an open position (such as is shown for example in Figs. 1A-B, 2, 3, and 4A-B) to a closed position (shown in Fig. 5B) as graspers 44 slide at least partially into hollow crimping shaft 28, thereby (b) crimping distal end 56 of prosthetic valve 22 from maximum uncrimped diameter Dla to fully crimped diameter D2. As shown in Fig. 5B, at the completion of this first phase of the crimping, distal end 56 of prosthetic valve 22 is crimped to fully crimped diameter D2. The remainder of prosthetic valve 22 remains uncrimped and is now seated against the inner wall 41 of funnel 40. For some applications a height H (shown in Fig. 4B) of funnel 40 from a proximal end 110 to a distal end 112 of funnel 40 is at least 40 mm and / or less than 60 mm.

[0067] For some applications, dimensions of prosthetic valve 22 may be one or more from the following list:

[0068] • fully crimped diameter D2 of prosthetic valve 22 is at least 4 mm and / or less than 11 mm;

[0069] • maximum uncrimped diameter Dla (shown in Fig. 4B) of distal end 56 of prosthetic valve 22 is at least 22 mm and / or less than 44 mm;

[0070] • maximum uncrimped diameter Dlb (shown in Fig. 4B) of a proximal end 57 of prosthetic valve 22 is at least 16 mm and / or less than 32 mm;

[0071] • a ratio of (i) maximum uncrimped diameter Dla of the distal end

[0072] 56 of prosthetic valve 22 to (ii) maximum uncrimped diameter Dlb of proximal end 57 of prosthetic valve 22 is at least 1 and / or less than 2;

[0073] • a ratio of (i) maximum uncrimped diameter Dla of distal end 56 of prosthetic valve 22 to (ii) fully crimped diameter D2 of prosthetic valve 22 is at least 2 and / or less than 11;

[0074] • an uncrimped length LI (shown in Fig. 4A) of prosthetic valve 22 from distal end 56 of prosthetic valve 22 to proximal end

[0075] 57 of prosthetic valve 22 is at least 10 mm and / or less than 40 mm;

[0076] • a fully crimped length L2 (shown in Fig. 7B) of prosthetic valve 22 from distal end 56 of prosthetic valve 22 to proximal end 57 of prosthetic valve 22 is at least 15 mm and / or less than 50 mm; and

[0077] • a ratio of (i) fully crimped length L2 of prosthetic valve 22 to (ii) uncrimped length LI of prosthetic valve 22 is at least 1 and / or less than 5.

[0078] As described hereinabove and as further described hereinbelow with respect to Figs. 7A-B, crimping the remainder of prosthetic valve 22 is achieved in a second phase of the crimping in which funnel 40 and crimping shaft 28 are slid proximally over prosthetic valve 22 such that inner wall 41 of funnel 40 causes the remainder of prosthetic valve 22 to crimp as the diameter of funnel 40 gradually decreases. The inventors have realized that crimping distal end 56 of prosthetic valve 22 which is grasped by graspers 44 can be done quickly, however crimping the reminder of prosthetic valve 22 by sliding funnel 40 over prosthetic valve 22 should be done in a slower and more controlled manner. Therefore, for some applications, the first stage of the crimping can be actuated by linearly pulling on graspers ' shaft 46 using pulling actuator 50 disposed at distal end 52 of graspers' shaft 46. In order to inhibit a user of crimping apparatus 20 accidentally pulling graspers' shaft 46 too far (for example, to a point where the crimping that should happen during the second phase of the crimping starts to occur) graspers' shaft 46 automatically engages with lock 54 once the set of graspers 44 has moved to the closed position, i.e. , once graspers' shaft 46 is distally pulled by a predetermined distance, e.g. , 20-100 mm. Further linear motion of the graspers' shaft with respect to housing 26 is thereby inhibited .

[0079] For some applications, lock 54 is seated within a hole 62 of outer grip 24 (shown in Fig. IB) . A corresponding hole 64 in housing 26 lines up with hole 62 (also shown in Fig. IB) such that (a) a locking protrusion 66 can interact with graspers' shaft 46, and (b) lock 54 is accessible to the user from the outside of outer grip 24 enabling lock 54 to be manually released (as further described hereinbelow with respect to Fig. 8) . Locking protrusion 66 engages with graspers' shaft 46 by sliding along a slot 68 in graspers' shaft 46 (shown more clearly in Fig. IB) as graspers' shaft 46 is pulled linearly. Locking protrusion 66 is coupled to a spring 70. A bar 72 is disposed within graspers' shaft 46 and pushes on locking protrusion 66 such that spring 70 is held in a compres sed state by bar 72 . As graspers ' shaft 46 is pulled linearly, locking protrus ion 66 s lides along bar 72 . In order to lock graspers ' shaft 46 in position once the first phase of the crimping has been completed, bar 72 has a hole 74 . When locking protrusion 66 reaches hole 74 as graspers ' shaft 46 is pulled linearly in the distal direction, spring 70 is released from its compres sed state and locking protrus ion 66 enters hole 74 thereby inhibiting further linear motion of graspers ' shaft 46 with respect to housing 26. Hole 74 is positioned such that graspers ' shaft 46 engages with lock 54 ( i . e . , locking protrusion 66 enters hole 74 ) upon graspers ' shaft 46 being linearly pulled in the distal direction a distance of at least 20 mm and / or less than 100 mm.

[0080] As described hereinabove , graspers ' shaft 46 is coaxial with hollow crimping shaft 28 , at least a portion of graspers ' shaft 46 is disposed within the hollow crimping shaft, and at least a portion of hollow crimping shaft 28 is disposed within hous ing 26 . When graspers ' shaft 46 is linearly pulled in the distal direction in the first phase of the crimping, hollow crimping shaft 28 remains stationary with respect to hous ing 26. Thus , the motion of graspers ' shaft 46 is relative to both hollow crimping shaft 28 and hous ing 26 . Since graspers ' shaft 46 is rigidly coupled to first end 48 of each grasper 44 , and second end 49 of each grasper 44 grasps distal end 56 of prosthetic valve 22 , as graspers ' shaft 46 is linearly pulled in the distal direction the set of graspers 44 s lides at least partially into hollow crimping shaft 28 . Hollow crimping shaft 28 thus causes the set of graspers 44 to move from the open position to the closed position as the set of graspers 44 s lide at least partially into hollow crimping shaft 28 .

[0081] Re ference is now made to Figs . 6 and 7A-B, which are schematic illustrations depicting the second phase of the crimping, in accordance with some applications of the present invention . For some applications , prior to the second phase of the crimping a guidewire lumen 76 of a transcatheter delivery system 78 is introduced into crimping apparatus 20 through the center of prosthetic valve 22 . A guidewire (not shown) is passed through guidewire lumen 76 . A delivery capsule 80 ( shown in Fig . 10 ) is made up of a proximal capsule 82 and a distal capsule 84 . Once prosthetic valve 22 is fully crimped it is loaded into proximal capsule 82 and subsequently distal capsule 84 is coupled to proximal capsule 82 to form closed delivery capsule 80 ready for transcatheter delivery to the patient . As shown in Fig . 6, when guidewire lumen 76 of delivery system 78 is placed through the center of prosthetic valve 22 , proximal capsule 82 is already disposed on guidewire lumen 76 , ready to receive prosthetic valve 22 once it has been fully crimped

[0082] For some applications , the second phase of the crimping is performed by s liding hollow crimping shaft 28 that has funnel 40 coupled to proximal end 38 of hollow crimping shaft 28 in a proximal direction over prosthetic valve 22 from crimped distal end 56 of the prosthetic valve (which was crimped during the first phase of the crimping described hereinabove ) , such that ( a) inner wall 41 of funnel 40 crimps the remainder of prosthetic valve 22 to fully crimped diameter D2 as funnel 40 s lides over prosthetic valve 22 , and (b ) hollow crimping shaft 28 slides over crimped prosthetic valve 22 until crimped prosthetic valve 22 is disposed entirely ins ide hollow crimping shaft 28 . For some applications , the s liding of hollow crimping shaft 28 is actuated by rotating crimping knob 34 as illustrated by arrows 86 in Fig . 7A. Rotation of crimping knob 34 causes hollow crimping shaft 28 to slide linearly in the proximal direction, as indicated by arrow 88 . As illustrated in cross -sectional view 90 of Fig . 7B, for some applications , interior threading on crimping knob 34 engages with threaded protrusions 32 on hollow crimping shaft 28 such that as crimping knob 34 is rotated in the direction shown by arrows 86, hollow crimping shaft 28 moves linearly in the proximal direction .

[0083] The linear motion of hollow crimping shaft 28 in the distal direction is with respect to the set of closed graspers 44 , thereby causing funnel 40 to slide in the proximal direction over prosthetic valve 22 from crimped distal end 56 of prosthetic valve 22 . For example , the linear motion of hollow crimping shaft 28 in the distal direction may be with respect to housing 26 while graspers ' 46 remains stationary with respect to hous ing 26, e . g . , while graspers ' shaft 46 is in a state in which graspers ' shaft 46 is engaged with lock 54 . This causes the motion of hollow crimping shaft 28 to be relative to the set of closed graspers 44 , which are grasping distal end 56 of prosthetic valve 22 . Thus , funnel 40 s lides in the proximal direction over prosthetic valve 22 from crimped distal end 56 of prosthetic valve 22 . For some applications , rotating crimping knob 34 comprises causing hollow crimping shaft 28 to s lide linearly at least 50 mm and / or less than 80 mm in the proximal direction .

[0084] Thus , for some applications , a method is provided including first ( i ) crimping distal end 56 of prosthetic valve 22 by grasping distal end 56 of prosthetic valve 22 with set of graspers 44 and collapsing the graspers from an open position to a closed pos ition by linearly pulling the set of graspers at least partially into hollow crimping shaft 28 that has funnel 40 coupled to proximal end 38 of hollow crimping shaft 28 , and then ( ii ) crimping the remainder of prosthetic valve 22 by rotation of crimping knob 34 , caus ing hollow crimping 28 shaft to s lide linearly in the proximal direction with respect to the set of closed graspers 44 , thereby causing funnel 40 to slide in the proximal direction over prosthetic valve 22 from crimped distal end 56 of prosthetic valve 22 , such that the inner wall 41 of funnel 40 crimps the remainder of prosthetic valve 22 as funnel 40 s lides over prosthetic valve 22 . Typically, as inner wall 41 of funnel 40 crimps the remainder of prosthetic valve 22 , hollow crimping shaft 28 slides over crimped prosthetic valve 22 until crimped prosthetic valve 22 is disposed entirely inside hollow crimping shaft 28 .

[0085] Re ference is now made to Figs . 8 and 9 , which are schematic illustrations showing the proces s of loading fully crimped prosthetic valve 22 onto delivery system 78 . After completion of the second phase of the crimping, prosthetic valve 22 is fully crimped and funnel 40 is disengaged from hollow crimping shaft 28 , e . g . , unscrewed from threaded portion 36 at proximal end 38 of hollow crimping shaft 28 . Funnel 40 is then removed by sliding funnel 40 proximally over guidewire lumen 76 and proximal capsule 82 . At a distal end of proximal capsule 82 there is a valve-coupling portion 92 . A series of coupling protrus ions 94 protrude from the proximal end of crimped prosthetic valve 22 such that proximal capsule 82 can be coupled to prosthetic valve 22 by coupling protrus ions 94 engaging valve-coupling portion 92 , as shown in the enlarged-view circles 96 and 98 of Fig . 8 . For some applications , rotation of a proximal capsule knob 100 , illustrated by arrows 102 ( shown in Fig . 9 ) drives proximal capsule 82 distally with respect to guidewire lumen 76 , i . e . , toward crimping apparatus 20 . As proximal capsule 82 is driven distally toward crimping apparatus 20 , prosthetic valve 22 is coupled to proximal capsule 82 . Once proximal capsule 82 is coupled to crimped prosthetic valve 22 , proximal capsule 82 can no longer move distally with respect to crimping apparatus 20 , e . g . , with respect to hollow crimping shaft 28 .

[0086] In order to pull crimped prosthetic valve 22 into proximal capsule 82 , lock 54 is manually released thereby allowing graspers ' shaft 46 to slide linearly with respect to hollow crimping shaft 28 . Thus , as proximal capsule knob 100 is further rotated, the distal motion of proximal capsule 82 with respect to guidewire lumen 76 pulls on crimped prosthetic valve 22 which in turn pulls on graspers ' shaft 46 in the proximal direction . Valve-coupling portion 92 along with crimped prosthetic valve 22 thus s lide into proximal capsule 82 . In order to release lock 54 , for some applications , a handle 104 , e . g . , the ring-shaped handle shown in Fig . 8 , of lock 54 is access ible from the outs ide of outer grip 24 . Handle 104 can be used to pull locking protrus ion 66 out of hole 74 in bar 72 , thus allowing graspers ' shaft 46 to slide linearly with respect to hollow crimping shaft 28 and with respect to housing 26.

[0087] Re ference is now made to Fig . 10 , which is a schematic illustration showing the connection of distal capsule 84 and thus the completion of the process of loading prosthetic valve 22 onto delivery system 78 , in accordance with some applications of the present invention . Once crimped prosthetic valve 22 is ins ide proximal capsule 82 , crimped prosthetic valve 22 is disconnected from graspers 44 (not shown) and a distal capsule 84 is introduced onto guidewire lumen 76 . For some applications , rotating a distal capsule knob 106 on delivery system 78 ( as illustrated by arrows 108 ) drives distal capsule 84 in the proximal direction with respect to guidewire lumen 76, thus connecting distal capsule 84 and proximal capsule 82 to form delivery capsule 80 which is now ready for transcatheter delivery of the prosthetic valve to the patient .

[0088] It will be appreciated by persons s killed in the art that the present invention is not limited to what has been particularly shown and described hereinabove . Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove , as well as variations and modi fications thereof that are not in the prior art , which would occur to persons s killed in the art upon reading the foregoing description .

Claims

CLAIMS1 . A method for crimping a prosthetic valve onto a delivery system, the method comprising : crimping a distal end of the prosthetic valve from a maximum diameter of the prosthetic valve to a fully crimped diameter of the prosthetic valve ; and sliding a hollow crimping shaft that has a funnel coupled to a proximal end of the hollow crimping shaft in a proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve , such that (a ) the inner wall of the funnel crimps the remainder of the prosthetic valve to the fully crimped diameter as the funnel slides over the prosthetic valve , and (b ) the hollow crimping shaft slides over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely ins ide the hollow crimping shaft .2 . The method according to claim 1 , wherein crimping the distal end of the prosthetic valve from the maximum diameter of the prosthetic valve to the fully crimped diameter of the prosthetic valve comprises : grasping a distal end of the prosthetic valve with a set of graspers and collaps ing the graspers from an open pos ition to a closed pos ition by sliding the set of graspers at least partially into the hollow crimping shaft .3 . The method according to claim 2 , wherein grasping the distal end of the prosthetic valve comprises grasping with the set of graspers a fabric portion of the prosthetic valve at the distal end of the prosthetic valve .4 . The method according to claim 2 , wherein grasping the distal end of the prosthetic valve comprises grasping with the set of graspers a wire frame of the prosthetic valve at the distal end of the prosthetic valve .5 . The method according to claim any one of claims 2 -4 , wherein s liding the hollow crimping shaft that has the funnel coupled to the proximal end of the hollow crimping shaft in the proximal direction comprises rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to slide linearly in the proximal direction with respect to the set of closed graspers , thereby causing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .6 . The method according to claim any one of claims 2 -5 , wherein grasping the distal end of the prosthetic valve with the set of graspers comprises grasping the distal end of the prosthetic valve with a set of 3 -9 graspers .7 . The method according to any one of claims 2 - 6 , wherein s liding the set of graspers at least partially into the hollow crimping shaft comprises linearly pulling on a graspers ' shaft in a distal direction with respect to a hous ing until the graspers ' shaft engages with a lock such that further linear motion of the graspers ' shaft with respect to the hous ing is inhibited, wherein :(a ) the graspers ' shaft is coaxial with the hollow crimping shaft , at least a portion of the graspers ' shaft is disposed within the hollow crimping shaft , and at least a portion of the hollow crimping shaft is disposed within the hous ing,(b ) linearly pulling on the graspers ' shaft in the distal direction comprises linearly pulling on the graspers ' shaft in the distal direction while the hollow crimping shaft remains stationary with respect to the housing, and(c ) the graspers ' shaft is rigidly coupled to a first end of each grasper of the set of graspers , wherein a second end of each grasper, oppos ite the first end, grasps the distal end of the prosthetic valve such that as the graspers ' shaft is linearly pulled in the distal direction the set of graspers s lides at least partially into the hollow crimping shaft, the hollow crimping shaft causing the set of graspers to move from the open pos ition to the closed position as the set of graspers s lide at least partially into the hollow crimping shaft .8 . The method according to claim 7 , wherein linearly pulling on the graspers ' shaft in the distal direction with respect to the housing until the graspers ' shaft engages with the lock comprises linearly pulling on the graspers ' shaft a distance of 20-100 mm .9 . The method according to claim 7 , wherein s liding the hollow crimping shaft that has the funnel coupled to the proximal end of the hollow crimping shaft in the proximal direction comprises rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to slide linearly in the proximal direction with respect to the housing, the graspers ' shaft being in a state in which the graspers ' shaft is engagedwith the lock, thereby caus ing the funnel to s lide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .10 . The method according to claim 9 , wherein rotating the crimping knob comprises causing the hollow crimping shaft to s lide linearly 50-80 mm in the proximal direction with respect to the hous ing .11 . Crimping apparatus for crimping a prosthetic valve onto a delivery system, the apparatus comprising : a set of graspers configured to grasp a distal end of the prosthetic valve ; a hollow crimping shaft arranged with respect to the graspers such that the graspers ( a) collapse from an open pos ition to a closed position as the graspers s lide at least partially into the hollow crimping shaft , thereby (b ) crimping the distal end of the prosthetic valve from a maximum uncrimped diameter of the distal end of the prosthetic valve to a fully crimped diameter of the prosthetic valve ; and a funnel coupled to a proximal end of the hollow crimping shaft , the hollow crimping shaft arranged to slide in a proximal direction with respect to the set of graspers such that (a) the funnel s lides in a proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve , whereby the inner wall of the funnel crimps the remainder of the prosthetic valve to the fully crimped diameter , and (b) the hollow crimping shaft s lides over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely ins ide the hollow crimping shaft .12 . The apparatus according to claim 11 , wherein : the funnel has a longitudinal axis , at any point x along the longitudinal axis the inner wall of the funnel has a radius r , and the second derivative d2 r / dx2 of the radius with respect to position x along the longitudinal axis is positive in a distal portion of the funnel and negative in a proximal portion of the funnel .13 . The apparatus according to any one of claims 11 -12 , wherein the set of graspers comprises 3-9 graspers .

14. The apparatus according to any one of claims 11-13, wherein a height of the funnel from a proximal end of the funnel to a distal end of the funnel is 40-60 mm.

15. The apparatus according to any one of claims 11-14, wherein the fully crimped diameter of the prosthetic valve is 4-11 mm.

16. The apparatus according to any one of claims 11-15, wherein a maximum uncrimped diameter of a proximal end of the prosthetic valve is 16-32 mm.

17. The apparatus according to any one of claims 11-16, wherein a maximum uncrimped diameter of the distal end of the prosthetic valve is 22-44 mm.

18. The apparatus according to any one of claims 11-17, wherein a ratio of (i) a maximum uncrimped diameter of the distal end of the prosthetic valve to (ii) a maximum uncrimped diameter of a proximal end of the prosthetic valve is 1-2.

19. The apparatus according to any one of claims 11-17, wherein a ratio of (i) a maximum uncrimped diameter of the distal end of the prosthetic valve to (ii) a fully crimped diameter of the prosthetic valve is 2-11.

20. The apparatus according to any one of claims 11-19, wherein an uncrimped length of the prosthetic valve from the distal end of the prosthetic valve to a proximal end of the prosthetic valve is 10-40 mm.

21. The apparatus according to any one of claims 11-20, wherein upon the remainder of the prosthetic valve being crimped, a fully crimped length of the prosthetic valve from the distal end of the prosthetic valve to a proximal end of the prosthetic valve is 15-50 mm.

22. The apparatus according to any one of claims 11-21, wherein an uncrimped length of the prosthetic valve from the distal end of the prosthetic valve to a proximal end of the prosthetic valve is 10-40 mm.

23. The apparatus according to any one of claims 11-20, wherein a ratio of (i) a fully crimped length of the prosthetic valve to (ii) an uncrimped length of the prosthetic valve is 1-5.

24. The apparatus according to any one of claims 11-23, wherein the set of graspers is configured to grasp the distal end of the prosthetic valve by grasping a fabric portion of the prosthetic valve at the distal end of the prosthetic valve.25 . The apparatus according to any one of claims 11 -24 , wherein the set of graspers is configured to grasp the distal end of the prosthetic valve by grasping a wire frame of the prosthetic valve at the distal end of the prosthetic valve .

26. The apparatus according to any one of claims 11 -25 , wherein the apparatus further comprises a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the set of closed graspers , thereby causing the funnel to s lide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .27 . The apparatus according to claim 26 , wherein the crimping knob and the hollow crimping shaft are arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly 50-80 mm in the proximal direction with respect to the set of closed graspers .28 . The apparatus according to any one of claims 11 -27 , wherein the apparatus further comprises :(A) a hous ing, at least a portion of the hollow crimping shaft disposed within the hous ing;(B) a graspers ' shaft :( i ) disposed coaxially with the hollow crimping shaft , at least a portion of the graspers ' shaft disposed within the hollow crimping shaft,( ii ) rigidly coupled to a first end of each grasper of the set of graspers , wherein a second end of each grasper, oppos ite the first end, grasps the distal end of the prosthetic valve , and( iii ) configured to be linearly pulled in a distal direction with respect to the housing while the hollow crimping shaft remains stationary with respect to the hous ing, thereby causing the set of graspers to slide at least partially into the hollow crimping shaft, the hollow crimping shaft causing the set of graspers to move from the open position to the closed pos ition as the set of graspers s lide at least partially into the hollow crimping shaft, and(C) a lock arranged such that the graspers ' shaft engages with the lock once the set of graspers has moved to the closed position, the lockconfigured to inhibit further linear motion of the graspers ' shaft with respect to the hous ing .29 . The apparatus according to claim 28 , wherein the lock and the graspers ' shaft are arranged such that the graspers ' shaft engages with the lock upon the graspers ' shaft being linearly pulled a distance of 20-100 mm in the distal direction with respect to the hous ing .30 . The apparatus according to claim 28 , wherein the apparatus further comprises a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to slide linearly in the proximal direction with respect to the hous ing, the graspers ' shaft being in a state in which the graspers ' shaft is engaged with the lock, thereby caus ing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve .31 . The apparatus according to claim 30 , wherein the crimping knob and the hollow crimping shaft are arranged such that rotation of the crimping knob causes the hollow crimping shaft to slide linearly 50-80 mm in the proximal direction with respect to the hous ing .32 . A method for crimping a prosthetic valve onto a delivery system, the method comprising : crimping a distal end of the prosthetic valve by grasping the distal end of the prosthetic valve with a set of graspers and collapsing the graspers from an open pos ition to a closed position by linearly pulling the set of graspers at least partially into a hollow crimping shaft that has a funnel coupled to a proximal end of the hollow crimping shaft ; and crimping the remainder of the prosthetic valve by rotating a crimping knob arranged such that rotation of the crimping knob causes the hollow crimping shaft to s lide linearly in the proximal direction with respect to the set of closed graspers , thereby causing the funnel to slide in the proximal direction over the prosthetic valve from the crimped distal end of the prosthetic valve , such that the inner wall of the funnel crimps the remainder of the prosthetic valve as the funnel slides over the prosthetic valve .33 . The method according to claim 32 , wherein as the inner wall of the funnel crimps the remainder of the prosthetic valve the hollow crimpingshaft slides over the crimped prosthetic valve until the crimped prosthetic valve is disposed entirely inside the hollow crimping shaft.

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